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Trial record 45 of 1927 for:    Sexually Transmitted Diseases | NIH

Adolescent Drug and HIV Prevention in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336180
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : March 21, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Edward A. Smith, Penn State University

Brief Summary:
The purpose of this trial is to test the effectiveness of a classroom-based prevention program (HealthWise: Learning Life Skills for Young Adults) to reduce the risk of HIV/AIDS and STIs, as well as substance use, among adolescents in one area of South Africa.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Sexually Transmitted Diseases Behavioral: HealthWise South Africa curriculum Phase 2 Phase 3

Detailed Description:

Recent estimates of the incidence of HIV among South African youth reveal rates to be among the highest in the world. Research shows that the sexual behaviors that put youth at increased risk for HIV often occur in the context of substance use. Consequently, effective prevention programs will most likely target both types of risk behavior. Research and theory also suggest that a positive youth development approach may be an useful way to reduce risk behavior. Therefore, our study involves the implementation of a classroom-based leisure, life-skill, and sexuality education curriculum, HealthWise: Learning Life Skills for Young Adults. This program is designed to reduce substance use and sexual risk behavior and to increase healthy leisure behavior and intra- and interpersonal skills.

Students from 4 high schools are currently receiving the HealthWise lessons in the 8th and 9th grades; students from 5 other schools serve as controls. Participants complete survey assessments on PalmPilots twice per year, until they leave school. Three cohorts of students are participating in this trial.

Our hypothesis is that HealthWise participants will engage in less risk behavior than controls. This will be tested using various statistical methodologies, including multiple regression, structural equation modeling, and growth modeling.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Adolescent Drug and HIV Prevention in South Africa
Study Start Date : September 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HW
The experimental group (HW) receives 18 classroom-based lessons on leisure motivation, life skills, and skills to avoid substance use and sexual risk.
Behavioral: HealthWise South Africa curriculum
18 classroom lessons

Primary Outcome Measures :
  1. incidence of ATOD use [ Time Frame: 2 years ]
  2. incidence of lifetime sexual intercourse [ Time Frame: 2 years ]
  3. rates of condom use [ Time Frame: 2 years ]
  4. number of sexual partners [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. knowledge and attitudes about substances and sex [ Time Frame: 2 years ]
  2. healthy leisure attitudes/behaviors [ Time Frame: 2 years ]
  3. levels of inter- and intrapersonal skills [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • attending one of nine secondary schools involved in the HealthWise South Africa research trial

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336180

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South Africa
University of the Western Cape
Bellville, South Africa, 7535
Sponsors and Collaborators
Penn State University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Edward A Smith, DrPH The Pennsylvania State University
Principal Investigator: Linda L Caldwell, PhD The Pennsylvania State University

Additional Information:
Caldwell L, Smith E, Wegner L, Vergnani T, Mpofu E, Flisher AJ, Mathews, C. HealthWise South Africa: Development of a life skills curriculum for young adults. World Leisure 3: 4-17, 2004.

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Responsible Party: Edward A. Smith, Interim Director, Penn State University Identifier: NCT00336180     History of Changes
Other Study ID Numbers: R01DA017491 ( U.S. NIH Grant/Contract )
R01DA017491 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: March 2013

Keywords provided by Edward A. Smith, Penn State University:
Adolescent behavior
Adolescent development
Drinking behavior
Health behavior
Reproductive Behavior
Sexual Behavior
South Africa

Additional relevant MeSH terms:
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Substance-Related Disorders
Sexually Transmitted Diseases
Chemically-Induced Disorders
Mental Disorders
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female